2. Why is there a need NOW for the ICH M10 guidance and for harmonization efforts?

Mark Arnold (left) and Rob Nelson (right) (Labcorp)

A call for harmonization of global bioanalytical regulations goes back to 2010 when AAPS, CFABS, APA and EBF representatives issued a joint letter calling for harmonization.  This led to the creation of the Global Bioanalysis Consortium (GBC) and the creation of other regional bioanalytical non-profit organizations in Brazil, China, and India.  Representatives to the GBC from these regional groups collaborated in writing a number of science-based best practice publications in 2016.  The aim of the publications was to set a global standard of science as the foundation for bioanalytical practices, to help influence regulatory agencies to approve of the recommendations.

Prior to the release of the publications and subsequently after, multiple health authorities issued new guidance that continued to propagate differences in requirements. These differences add complexity for any bioanalytical lab in performing work that will be submitted globally. Ideally, ICH M10 will standardize requirements and prevent any further country/regional differences in regulatory expectations.

 Kelly Dong (United-Power Pharma Tech Co., Ltd.,)

There are multiple regulatory guidelines currently in place across the globe. Although the majority of the requirements and acceptance criteria are similar, there are still a number of specific regional differences concerning requirements and practices (e.g. freshly prepared vs frozen calibration standards in ligand-binding assay studies). Considering the trend of globalization in therapeutic development, these differences could inevitably result in inconsistent practices and sometimes additional bioanalytical effort in method evaluation, particularly for studies intended for global submission. Therefore, it would be highly advantageous to adopt an internationally harmonized standard to ensure data consistency and quality.

The opinions expressed in this feature are those of the authors and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.